FDA issues acetaminophen overdose warning

Sunday

Feb 9, 2014 at 2:00 AM

PORTSMOUTH — The Food and Drug Administration has issued a recommendation about discontinuing the inclusion of acetaminophen in prescribed medications, due to the risk of overdose and possible liver injury.

Karen Dandurant

PORTSMOUTH — The Food and Drug Administration has issued a recommendation about discontinuing the inclusion of acetaminophen in prescribed medications, due to the risk of overdose and possible liver injury.

Acetaminophen is a common analgesic used in the relief of pain. The danger comes because it is also a common over-the-counter drug and the risk of overdose comes into play. The FDA says prescribed combination drugs should not contain more than 325 milligrams of acetaminophen. The recommendation was issued to manufacturers in 2011, to be implemented by January 2014.

According to the FDA, there is no data to show the added benefits of including acetaminophen in prescribed medication outweighs the risk of liver injury. Inadvertent overdoses of the drug can lead to liver failure, the need for liver transplant, and in some rare cases, death can result.

The action targets prescription analgesics that may have as much as 750 milligrams per dose of acetaminophen. The FDA is currently advising that health care providers stick to products that contain no more than 325 milligrams per tablet.

Liver injuries have been reported in patients who took more than the prescribed dosage in a 24-hour period, often through more than one product. Alcohol consumption during use increases the risk.

The combination of acetaminophen with opioid pain medication has been commonly prescribed for injuries, post-operative pain and many dental procedures. Patients may also use acetaminophen as over-the-counter pain relief, and it can be found in many cough and cold medications. The FDA is looking to address the use in cold medications in the near future. Physicians are advised to consider the combination when prescribing medicine.

Dr. Arthur Yan of Core Gastroenterology in Exeter said most liver failures they see from overdoses are intentional, suicide attempts by poisoning. He said the rest are unintentional, accidental overuse of common drugs like acetaminophen.

"Narcotics like Percocet, Vicodin and even Tylenol with codeine are prescribed for pain," Yan said. "Some people may be unaware of the acetaminophen component. They may still have pain, so they take over-the-counter acetaminophen. Damage can come from a one-time mistake. If a person takes more than 12 grams in a 24-hour period, that's a potential overdose. The liver is constantly metabolizing the drug, but there is a limit, and liver injury is likely."

Yan said that within 24 to 48 hours of an overdose, a patient will likely have nausea and vomiting. They may feel lethargic.

"We can start to see an increase in liver enzymes," Yan said. "There may be confusion. If there is too much damage, the treatment at that point may only be through a transplant. We don't see a lot of this, but when we do, it's usually pretty bad."

Despite the 2011 FDA recommendation, Yan said the combination drugs are still used. Since this is the case, he said it is important for the physician to do thorough counseling with their patient about the danger, and to be sure they take a complete medical history to know everything the patient might be using.

The problem is that many people believe over-the-counter drugs are safe, and if used properly, they are. But, they are still drugs, and can be abused.

"We need to ask about over-the-counter drugs, and even herbal medicines," Yan said. "And, if they use alcohol, how much is an important question to ask, because that combined with acetaminophen can increase the danger."

Yan said for most people, the issue does not arise. Those he worries about are patients who have chronic pain and are looking to alleviate their symptoms.

Still, Yan said he believes there is a good synergistic effect in using the combination drugs. As long as care is taken to assure the patient understands the risks of adding other over-the-counter treatments, he said they should be safe.

Advertise

Original content available for non-commercial use under a Creative Commons license, except where noted.
seacoastonline.com ~ 111 New Hampshire Ave., Portsmouth, NH 03801 ~ Privacy Policy ~ Terms Of Service